Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis

Summary

To assess the safety and efficacy of PACK-CXL (photoactivated chromophore for infectious keratitis cross-linking) as a firstline treatment for infectious corneal infiltrates and early corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.

Conditions

• Keratitis; Infectious Disease (Manifestation)

Interventions

DEVICE

PACK-CXL

Local anesthesia \- Oxybuprocaine or Tetracaine, 1 drop each, applied together, every 3 minutes, total of 3 times Abrasio - Abrasio: 1 mm around the borders of the infiltrate/ulcer Corneal scrape Hypo-osmolaric riboflavin solution \- Apply one drop every 2 minutes for 20 minutes UV-A irradiation * 3 mW/cm2 for 30 minutes or 9 mW/cm2 for 10 minutes, 18 mW/cm2 for 5 minutes, 30 mW/cm2 for 3 minutes all allowed (see paper Richoz et al) * Treatment diameter: use a irradiation diameter of 6 to 8 mm, keep the infiltrate/ulcus centered. Additional postoperative treatment * Homatropin or Scopolamin, if anterior chamber reaction * Systemic NSAID/NSAR, if substantial pain * Do not use: topical or systemic steroids, topical NSAID/NSAR, paracetamol, vitamin A ointment, patching

DRUG

Cefazolin in combination with either tobramycin or gentamicin

Control arm consists of standard topical antimicrobial therapy recommended for the treatment of microbial keratitis by the American Academy of Ophthalmology. Initial empiric topical antibiotic therapy (eye drops or ocular ointment): 1a. Cefazolin (50mg/ml) in combination with either tobramycin (9-14mg/ml) or gentamicin (9-14mg/ml).

DRUG

Cycloplegic agents (cyclopentolate 1% eye drops)

Cycloplegic agents (cyclopentolate 1% eye drops): to decrease pain and synechia risk is at the physician discretion.

DRUG

Fluoroquinolones (Besifloxacin ; ciprofloxacin ; gatifloxacin ; levofloxacin ; moxifloxacin ; ofloxacin )

Fluoroquinolones (Besifloxacin 6 mg/ml; ciprofloxacin 3 mg/ml; gatifloxacin 3 mg/ml; levofloxacin 15 mg/ml; moxifloxacin 5 mg/ml; ofloxacin 3 mg/ml)

DRUG

Corticosteroids (prednisolone acetate 0.5% or 1% eye drops)

Corticosteroids (prednisolone acetate 0.5% or 1% eye drops): use of corticosteroids for patients included in the study only after complete closure of the epithelium

Sponsors & Collaborators

• University Hospital, Geneva

  lead OTHER

Principal Investigators

• Farhad Hafezi, MD, PhD · [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2020-10-31

Completion

2020-10-31

Countries

• Switzerland

Study Locations